Product details
WHO Product ID
WHOAPI-401
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Neglected tropical diseases
Type
None
Grade
Standard
INN
Miltefosine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Zydus Lifesciences Limited
5/1-B, G.I.D.C., Industrial Estate, Bharuch
Ankleshwar,
Gujarat
393002
India
APIMF Version Number
AP/MLL/A/Ver-001
RP/MLL/A/Ver-001
RP/MLL/A/Ver-001
Product Grades
API specification number
QC/SPC/DS/B444-09
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
The drug substance is packed in HM-HDPE bag (transparent) under nitrogen atmosphere and closed with twist & tie, followed by another HM-HDPE bag under nitrogen atmosphere and closed with twist & tie. Then the double HM-HDPE bag is placed into triple laminated high barrier aluminum bag and closed with heat seal. Finally triple laminated aluminum bag is transferred and packed in HDPE drum.
API Manufacturing Site(s)
Zydus Lifesciences Limited
5/1-B, G.I.D.C., Industrial Estate, Bharuch
Ankleshwar,
Gujarat
393002
India